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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04294667




Registration number
NCT04294667
Ethics application status
Date submitted
27/02/2020
Date registered
4/03/2020

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2019-003406-27
Secondary ID [2] 0 0
SL0043
Universal Trial Number (UTN)
Trial acronym
PHOENYCS GO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DZP
Other interventions - Placebo

Experimental: Dapirolizumab pegol - Subjects will receive dapriolizumab pegol througout the Treatment Period.

Placebo comparator: Placebo - Subjects will receive placebo througout the Treatment Period.


Treatment: Drugs: DZP
Subjects will receive dapirolizumab pegol at prespecified time-points.

Other interventions: Placebo
Subjects will receive placebo at prespecified time-points.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of BICLA response at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Achievement of BICLA response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Achievement of BICLA response at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
Timepoint [3] 0 0
During Treatment Period up to Week 48
Secondary outcome [4] 0 0
Achievement of LLDAS in =50% of post-Baseline visits through Week 48
Timepoint [4] 0 0
During Treatment Period up to Week 48
Secondary outcome [5] 0 0
Change from Baseline in SLEDAI-2K at Week 48
Timepoint [5] 0 0
From Baseline (Day 1) to Week 48
Secondary outcome [6] 0 0
Achievement of BILAG improvement without worsening at Week 48
Timepoint [6] 0 0
Week 48
Secondary outcome [7] 0 0
Change from Baseline in PGA at Week 48
Timepoint [7] 0 0
From Baseline (Day 1) to Week 48
Secondary outcome [8] 0 0
Achievement of SRI4 response at Week 48
Timepoint [8] 0 0
Week 48
Secondary outcome [9] 0 0
Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48
Timepoint [9] 0 0
During Treatment Period up to Week 48
Secondary outcome [10] 0 0
Time to severe BILAG Flare through Week 48
Timepoint [10] 0 0
During Treatment Period up to Week 48
Secondary outcome [11] 0 0
Time to moderate/severe BILAG flare through Week 48
Timepoint [11] 0 0
During Treatment Period up to Week 48
Secondary outcome [12] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Timepoint [12] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
Secondary outcome [13] 0 0
Percentage of participants with serious treatment-emergent adverse events during the study
Timepoint [13] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
Secondary outcome [14] 0 0
Percentage of participants with treatment-emergent adverse events of special interest during the study
Timepoint [14] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
Secondary outcome [15] 0 0
Percentage of participants with treatment-emergent adverse events of special monitoring during the study
Timepoint [15] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 54)

Eligibility
Key inclusion criteria
* Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
* Study participant must be =16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
* Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:

a. Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d (where available) as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:

1. Anti-Smith (anti-Sm) antibodies (central laboratory) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historic evidence for anti-dsDNA antibodies

d. Moderately to severely active defined as
* British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in =2 organ systems and/or a BILAG 2004 Grade A in =1 organ systems at Screening and Baseline Visit AND
* Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) =6 at Screening Visit AND
* SLEDAI-2K without labs =4 at Baseline Visit

e. Receiving the following SOC medication at stable dose:
* Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life threatening condition
* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
* Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
* Study participant had a reactivated latent infection (example, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2), or is currently receiving suppressive therapy for an opportunistic infection
* Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
* Study participant has clinically significant active or latent infection
* Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
* Study participant takes any protocol defined prohibited concomitant medication
* Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
* Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP
* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate <30mL/min/1.73m^2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/06/2024
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sl0043 30020 - Parkville
Recruitment hospital [2] 0 0
Sl0043 30025 - St Albans
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment postcode(s) [2] 0 0
- St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
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Colorado
Country [5] 0 0
United States of America
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Connecticut
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District of Columbia
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Florida
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Georgia
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Idaho
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United States of America
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Illinois
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Kentucky
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Louisiana
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Maryland
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Michigan
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Washington
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West Virginia
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Argentina
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Capital Federal
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Mendoza
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Argentina
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Quilmes
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Argentina
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San Juan
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Argentina
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Tucuman
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Austria
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Graz
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Liege
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Calgary
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Canada
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Edmonton
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Canada
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Rimouski
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Toronto
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Trois-rivieres
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Providencia, Santiago
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Santiago de Chile
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Santiago
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Bogota
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Chia
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Medellín
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Monteria
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Praha 2
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Odense
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France
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Montpellier Cedex 5
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France
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Paris Cedex 12
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Germany
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Cologne
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Germany
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Dessau
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Germany
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Dresden
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Freiburg
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Hanover
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Herne
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Leipzig
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Tübingen
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Athens
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Crete
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Haidari - Athens
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Larisa
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Thessaloniki
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Budapest
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Debrecen
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Gyula
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Szeged
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Szekesfehervar
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Italy
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Catania
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Italy
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Rozzano
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Korea, Republic of
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Busan
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Daejeon
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Korea, Republic of
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Incheon
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Seoul
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Mexico
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Chihuahua
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Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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Leon
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Mexico
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Merida
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Mexico
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Monterrey
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Peru
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Arequipa
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Peru
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Lima
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Philippines
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Angeles
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Philippines
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Davao
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Philippines
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Makati
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Philippines
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Manila
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Nadarzyn
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Galati
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Serbia
State/province [108] 0 0
Belgrade
Country [109] 0 0
Serbia
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Kragujevac
Country [110] 0 0
Serbia
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Novi Sad
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Málaga
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Spain
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Mérida
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Spain
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Sabadell
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Spain
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Sevilla
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Spain
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Vigo
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Taiwan
State/province [118] 0 0
Taichung City
Country [119] 0 0
Taiwan
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Taipei City
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04294667